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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GREINER BIO-ONE GMBH MINICOLLECT FUNNEL SPECIMEN TRANSPORT AND STORAGE CONTAINER

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GREINER BIO-ONE GMBH MINICOLLECT FUNNEL SPECIMEN TRANSPORT AND STORAGE CONTAINER Back to Search Results
Model Number 450421
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
Complaint (b)(4). We did not receive samples from the customer for further investigation. We have no further complaints on the material/batch. We have no further inventory of the material/batch.
 
Event Description
Customer states that clotting is occurring in the funnel as blood is being collected. Customer states specimen collected with funnel was hemolyzed and could not be used for testing. Customer advises these issues are resulting in late patient results and multiple sticks. Specimens are being collected by heel stick. A new funnel is being used with each tube. Multiple sites are having these issues.
 
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Brand NameMINICOLLECT FUNNEL
Type of DeviceSPECIMEN TRANSPORT AND STORAGE CONTAINER
Manufacturer (Section D)
GREINER BIO-ONE GMBH
bad haller strasse 32
kremsmuenster oberosterreich, austria AT A -455
AU AT A-4550
Manufacturer (Section G)
GREINER BIO-ONE NA INC
4238 capital drive
monroe, nc
Manufacturer Contact
manfred abel
4238 capital drive
monroe, nc 
2617823
MDR Report Key10425886
MDR Text Key205679328
Report Number8020040-2020-00002
Device Sequence Number1
Product Code FMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number450421
Device Catalogue Number450421
Device Lot Number191002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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